Introduction to Extractables & Leachables Testing
This course will give participants an understanding of how polymeric materials are used in pharmaceutical products and how additives and other materials related to those polymers i.e. the extractables and leachables, may be of concern or risk to the patient. The course will also cover the regulatory aspects and requirements relating to E & L, and will highlight some of the guidelines developed to assist medical companies in defining strategy and limits for testing. Analytical methodology, instrumentation and sample preparation will be discussed and the basic steps required for performing an E & L study will be described, including stability plans and method validation. Case studies will be used to demonstrate the processes involved.